Pharmaceutical CSV Specialist

Philadelphia, PA

Job ID: 132996 Industry: Pharmaceutical

Pharmaceutical CSV Specialist

Project Description:

Our client is a leading gene therapy organization looking for an experienced CSV Specialist for development and management of systems change controls and documentation, 

Day to Day Responsibilities:

The client is looking for an experienced Computer Systems Validation Specialist to assist in the overall development and maintenance of GxP system life cycle documentation.    This person must have over 7 years of experience working within an FDA regulated environment specific to Computer Systems Validation.  This individual will be required to facilitate, prepare and execute CSV documents for Technical Operations, QC, QA, R&D, and IT groups as necessary therefore they must be an expert in be able to perform all change control requests, deviations, and documentation.  This is a cross-functional role, therefore strong communication skills are required.    

This individual must be comfortable reviewing, approving, and executing  documentation including:  Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ/UAT), Requirements Trace-ability Matrices, Validation Summary Reports, SOP' s, Change Control, and Risk assessment reports.  

  • CSV (7+ years)
  • IQ, OQ, UAT
  • GAMP 5
  • GxP Compliance
  • B.S. Degree
  • Pharmaceuticals  

Desired Skills:
  • B.S. in Computer-Systems, Information Systems, or Computer Engineering

Job Type: Contract  

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